5-amino-2,4,6-triiodoisophthalic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1991

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-2,4,6-triiodoisophthalic acid

EC Number:

252-575-4

EC Name:

5-amino-2,4,6-triiodoisophthalic acid

Cas Number:

35453-19-1

Molecular formula:

C8H4I3NO4

IUPAC Name:

5-amino-2,4,6-triiodobenzene-1,3-dicarboxylic acid

Details on test material:

Test substance was stored at room temperature in the dark in a closed cabinet.
The test substance was directly dissolved in distilled water.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female Sprague-Dawley rats from BRL (Switzerland) were used. The average weight of the animals at the beginning of the treatment was 200 g +/- 10% for males and 180 g +/- 10% for females.
Rats were housed by groups of 2 or 3 of the same sex in Makrolon type III cages. The animal room was located in the B building (basement) of Battelle-Geneva.
Except for the periods of starvation as defined in the protocol, rats received food 8kliba, Kaiseraugst, ref. 24-343) and water (tap water, from a water bottle) ad libitum.
Rats were placed on a sawdust bedding in their cages.
Animals were identified individually with an ear tattoo. The animal numbers were sequential.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was administered by gastric intubation, from a solution in water, in order to administer three different doses (low, medium and high).
Doses were adjusted by administering variable volumes, that were determined according to the rat body weights measured just before the administration.
The substance was administered during the morning in order to perform the clinical examination during the afternoon.

Doses:

1500 mg/kg
3000 mg/kg
6000 mg/kg

No. of animals per sex per dose:

5 males per dose
5 females per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined every day for clinical observation, and they were individually weighed once a week during the observation period and terminal body weights were recorded at necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy findings.

Statistics:

The only statistical analyses which were performed are ANOVA t-tests on body weights between the treated groups and the room control to verify whether the growth curve of the animals is affected by the treatment. The results of these statistical analyses are stored in the Study Archives with the raw data.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Mortality:

2 males
2 females
(see following table)

Clinical signs:

other: Laboured breathing in high dose males for 2 days post-treatment.

Gross pathology:

No abnormal findings in survivors, product in lungs or pulmonary hemorrhages in animals found dead.

Any other information on results incl. tables

Mortality:

Dose (mg/kg)	Males	Females
1500	0	0
3000	1*	0
6000	1*	2*

* death is due to accidental trauma/inspiration during gavage

Day first deat: 1

Day last death: 7

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No mortality due to the treatment. The substance is harmless.